1. Beverley Alberola, CIP Associate Director, Research Protections
IRB Member Training
Beverley Alberola, CIP
Associate Director, Research Protections

2. Topics of Discussion The Vice Chancellor for Research The UCI IRB
The IRB: What to Know
The IRB Review Process
Resources

3. The Vice Chancellor for Research
Safeguarding the rights and welfare of human participants in research and other research activities is a general Institutional policy delegated by the Chancellor through the Vice Chancellor for Research.
The Vice Chancellor for Research is the Institutional Official. It is his responsibility to exercise appropriate administrative oversight to assure that UCI’s policies and procedures designed for protecting the rights and welfare of human participants are effectively applied in compliance with its Assurance.
At UCI, the Vice Chancellor for Research is Pramod Khargonekar, PhD.

4. The UCI IRB
The IRB is a committee of physicians, scientists, advocates and members of the community who come together to review research protocols.
The IRB has the oversight responsibility for protecting the rights and welfare of research participants.
The IRB Committees are required to have a minimum of five members each, with varying backgrounds and expertise to provide complete and thorough review of research activities commonly conducted by the Institution.
Each IRB Committee must include at least one member whose primary interests are in a scientific area, one member whose primary interests are in a non-scientific area and one member who is not affiliated with UCI (i.e. not a family member or spouse of an employee, not an active alumnus).
At least one non-affiliated member and one non-scientist are present at convened meetings.
UCI IRBs are registered with the Department of Health and Human Services (HHS) as HHS regulations at 45 CFR part 46, subpart E, require all IRBs to register if they will review human subjects research conducted or supported by HHS and are to be designated under an assurance of compliance approved for Federalwide use by OHRP.

5. The UCI IRB
At UCI, there are 2 main biomedical IRBs; 1 social / behavioral / educational IRB.
For greater than minimal risk research, full committee meetings are held monthly.
For minimal risk research, subcommittee meetings are held weekly.
Some Human Research Protections (HRP) staff are IRB members for processing straightforward, minimal risk transactions within the office.
For other transactions, such as personnel changes, non-IRB member HRP staff have been delegated authority to review and approve.

6. The UCI IRB
IRB Members take an additional CITI training module – designed specifically for their role.
Additional education is provided at each convened meeting. Typically, training relates to topics covered in that meeting’s agenda.

7. The UCI IRB Chairs Biomedical Chairs: Tahseen Mozaffar, MD
Kenneth Linden, MD, PhD
Social/ Behavioral / Educational Chair:
Elizabeth Cauffman, PhD

8. The IRB: What to Know The IRB considers 2 sets of regulations:
Department of Health and Services (DHHS), Office of Human Research Protections (OHRP), Code of Federal Regulations (CFR) Title 45, Parts 46
Food and Drug Administration (FDA), CFR Title 21, parts 50, 54 and 56, 312 (drugs) & 812 (devices)

9. It is the role of HRP Staff to help ensure basic regulatory considerations are addressed, prior to IRB review.
The IRB: What to Know

10. Required Elements of Consent*
It is the role of HRP Staff to help ensure basic regulatory considerations are addressed, prior to IRB review.
The IRB: What to Know
Required Elements of Consent*
A statement that the study involves research
An explanation of the procedures of the research
A description of the procedures to be followed & duration
A description of any reasonably foreseeable risks or discomforts to the subject.
A description of any benefits to the subject or to others which may reasonably be expected from the research.
A disclosure of appropriate alternative procedures or courses of treatment, if any
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights
A statement that participation is voluntary
*Additional elements will apply if broad consent is obtained

11. The IRB: What to Know
The IRB reviews each protocol to ensure that the criteria for approval has been met.
The IRB has the authority to approve a protocol (aka “A”), require specific changes (aka “M” for minor changes – also known as approved with conditions), or table a protocol (aka “T”) when significant issues are noted.
The IRB may (rarely) disapprove a protocol. This occurs after significant effort has been made to work with the research team – to help the protocol meet criteria for IRB approval. Once disapproval occurs, not even the Vice-Chancellor for Research can overturn the IRB’s decision.
Conversely, the IRB may approve a protocol and the Vice-Chancellor for Research can disapprove.

12. The IRB Review Process

13. The IRB Review Process
If you are assigned as a Primary or Secondary Reviewer, you will need to complete the Reviewer’s Checklist. This document is uploaded in the e-agenda, along with all pertinent review materials, such as the Protocol Narrative, Consent Form, Master Protocol and Investigator’s Brochure.
The Checklist addresses elements of IRB approval and elements of consent.
Specific questions and concerns from Human Research Protection (HRP) Staff will be included for your response / comments.
Some special determinations will need to be made – may involve Supplemental Checklists. This will be noted on the Checklist and the agenda.
Make sure all sections are complete; sign the checklist & hand to HRP Staff after the meeting.
Any questions prior to the meeting? Please contact HRP Staff (the IRB Administrator, Senior IRB Analyst or IRB Analyst).

14. Resources At the Meeting: Agenda IRB Chair IRB Members
Laminated Sheets Help with Voting / Determinations
HRP Staff! (at the meeting – or anytime…that’s what we are here for!)
Other Resources:
ORA Website- page for IRB Members